1 день назад
Local Clinical Study Manager (Eastern Europe)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Local Clinical Study Manager (Eastern Europe) (Oncology): Managing the operational and scientific oversight, setup, execution, and delivery of oncology and onco-hematology clinical trials in Eastern European countries with an accent on cross-functional leadership, regulatory compliance, and clinical data quality. Focus on coordinating clinical teams, resolving site and data risks, supporting trial-site activation, and maintaining inspection readiness under ICH GCP and local regulations.
Location: Home-based in Prague, Czech Republic; only candidates based in the listed location will be considered.
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Lead the operational and scientific oversight, setup, execution, and delivery of assigned clinical trials in Eastern European countries.
- Plan and coordinate day-to-day monitoring activities, study commitments, timelines, data quality, and clinical deliverables.
- Lead cross-functional clinical teams and coordinate local startup, regulatory, in-house clinical, and global staff.
- Support site activation and monitoring, review site visit reports, and drive follow-up and resolution of site issues.
- Identify data and operational risks, develop mitigation plans, and maintain study-specific plans, documents, and tools.
- Ensure regulatory reporting, renewals, progress updates, and end-of-study notifications comply with the protocol, local regulations, and ICH GCP.
Requirements
- Bachelor’s degree in a related discipline, preferably life science.
- At least five years of clinical research experience, including at least two years of project management experience or equivalent experience.
- Previous experience in oncology or onco-hematology is required.
- Good knowledge of ICH GCP, relevant local regulations, the drug development process, and clinical operations.
- Proven ability to lead cross-functional teams and deliver clinical trials on time, within budget, and to the required quality standards.
- Excellent spoken and written English is required.
Culture & Benefits
- Full-time, home-based working arrangement.
- Opportunity to work on clinical research projects across different therapeutic areas.
- Close collaboration with a key sponsor client and international clinical teams.
- Work focused on developing and commercializing innovative medical treatments and improving patient outcomes.
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